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Cognitive Behavioral Therapy for Irritable Bowel Syndrome (U54_P3_CBT Trial)
U54_P3_CBT Trial Summary
This trial will use CBT to study the relationship between the brain, the gut microbiome, and symptomatic outcome in IBS patients, with the goal of identifying the role of sex differences in these relationships.
U54_P3_CBT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowU54_P3_CBT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.U54_P3_CBT Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding and haven't been for at least 6 months.I am between 18 and 55 years old.I will use non-hormonal birth control or avoid pregnancy during the study.I haven't taken antibiotics or probiotics within 3 months before joining the study.I use hormonal birth control and still have a monthly period.I don't have unexplained weight loss, fevers, anemia, or blood in my stools.I haven't had cancer, except for treated skin cancer, in the last 5 years.My average abdominal pain is 3 or more on a scale of 0 to 10.I have been practicing or completed CBT therapy within the last 2 years.I am a premenopausal woman not pregnant or breastfeeding, willing to use non-hormonal birth control.I regularly use narcotics or opioids.I have had chronic pain for more than 6 months, not related to IBS.I can walk without relying solely on a wheelchair.I haven't experienced unexplained weight loss, fevers, anemia, or blood in my stools.I am a woman who has not gone through menopause and still gets periods.I have not had major surgery in the last 6 months and do not plan to have any during the study.I can speak English fluently.My IBS is at least moderately severe according to the IB-SSS.My BMI is over 35.I haven't used any experimental drugs or devices in the last 28 days.I have been diagnosed with or show symptoms of Irritable Bowel Syndrome.I have been diagnosed with or show symptoms of IBS.I can walk without relying solely on a wheelchair.I am between 18 and 55 years old.I haven't experienced unexplained weight loss, fevers, anemia, or blood in my stools.
- Group 1: Cognitive Behavioral Treatment Arm
- Group 2: Usual Care Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Might I be a viable candidate to participate in this research?
"This trial is looking to include 150 patients who are aged between 18 and 55 with a diagnosis of irritable bowel syndrome."
Is this study currently open to accept new participants?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting patients since it was posted on December 18th 2021 and recently revised on January 20th 2022. This trial necessitates 150 individuals from a single site for participation."
Does the age range for participation in this study extend to those under 35?
"This trial specifically caters to individuals aged 18-55. For those younger than 18, there are 13 other trials available and for senior citizens over 65, 79 different studies may offer solutions."
What is the sample size of this research project?
"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients; the trial was initially posted on December 18th 2021 and its most recent update took place on January 20th 2022. 150 participants are needed from 1 site for successful completion of the research."
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